NCT00640900

Brief Summary

This study will provide data on the response over 24 months to two commercial weight loss programs (center-based and telephone-based) compared to control conditions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 1, 2008

Status Verified

March 1, 2008

Enrollment Period

2 years

First QC Date

March 18, 2008

Last Update Submit

March 31, 2008

Conditions

OverweightObesity

Keywords

overweightobesityweight losscommercial weight loss program

Outcome Measures

Primary Outcomes (1)

  • weight loss

    2 year

Study Arms (3)

Commercial program at center

EXPERIMENTAL
Behavioral: Commercial weight loss program

Commercial program over the telephone

EXPERIMENTAL
Behavioral: Commercial weight loss program

Usual care

OTHER

Weight loss counseling

Behavioral: Usual care

Interventions

Usual careBEHAVIORAL

Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.

Usual care
Commercial weight loss programBEHAVIORAL

Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.

Commercial program at centerCommercial program over the telephone

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years and older
  • Initial BMI \>25.0 kg/m2 and \<40 kg/m2
  • A minimum of 15 kg over ideal weight as defined by the 1983 Metropolitan Life Insurance tables
  • Willing and able to participate in clinic visits and JC facility interactions at specified intervals and to maintain contact with the investigators for 24 months
  • Willing to allow blood collections
  • Capable of performing a simple test for assessing cardiopulmonary fitness

You may not qualify if:

  • Inability to participate in physical activity because of severe disability (e.g., severe arthritic conditions)
  • A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
  • Self-reported pregnancy or breastfeeding or planning a pregnancy within the next two years
  • Currently actively involved in another diet intervention study or organized weight loss program
  • Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (4)

  • Dow CA, Thomson CA, Flatt SW, Sherwood NE, Pakiz B, Rock CL. Predictors of improvement in cardiometabolic risk factors with weight loss in women. J Am Heart Assoc. 2013 Dec 18;2(6):e000152. doi: 10.1161/JAHA.113.000152.

    PMID: 24351700DERIVED

  • Thomson CA, Morrow KL, Flatt SW, Wertheim BC, Perfect MM, Ravia JJ, Sherwood NE, Karanja N, Rock CL. Relationship between sleep quality and quantity and weight loss in women participating in a weight-loss intervention trial. Obesity (Silver Spring). 2012 Jul;20(7):1419-25. doi: 10.1038/oby.2012.62. Epub 2012 Mar 8.

    PMID: 22402738DERIVED

  • Rock CL, Emond JA, Flatt SW, Heath DD, Karanja N, Pakiz B, Sherwood NE, Thomson CA. Weight loss is associated with increased serum 25-hydroxyvitamin D in overweight or obese women. Obesity (Silver Spring). 2012 Nov;20(11):2296-301. doi: 10.1038/oby.2012.57. Epub 2012 Mar 8.

    PMID: 22402737DERIVED

  • Rock CL, Flatt SW, Sherwood NE, Karanja N, Pakiz B, Thomson CA. Effect of a free prepared meal and incentivized weight loss program on weight loss and weight loss maintenance in obese and overweight women: a randomized controlled trial. JAMA. 2010 Oct 27;304(16):1803-10. doi: 10.1001/jama.2010.1503. Epub 2010 Oct 9.

    PMID: 20935338DERIVED

MeSH Terms

Conditions

OverweightObesityWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Cheryl L Rock, PhD, RD

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 21, 2008

Study Start

July 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2010

Last Updated

April 1, 2008

Record last verified: 2008-03

Locations

US(1)